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Hospital-based case control study to assess vaccine effectiveness against Novel Influenza A (H1N1) and occurance of severe acute respiratory infections (SARI) in adults between 18 and 65 years of age in Berlin, 2009-10

Hospital-based case control study to assess vaccine effectiveness against Novel Influenza A (H1N1) and occurance of severe acute respiratory infections (SARI) in adults between 18 and 65 years of age in Berlin, 2009-10 - Influenza-Impfeffektivitätsstudie (IIE-Studie)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00000277
Enrollment
2400
Registered
2009-12-09
Start date
2009-12-08
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

2009 Novel Influenza A (H1N1)

Interventions

Group 1: Among cases (acute respiratory infections or PCR-confirmed influenza) the following propotion will be assessed: Persons with and without vaccination against 2009 Novel Influenza A (H1N1) Grou

Sponsors

Robert Koch-Institut, Abteilung für Infektionsepidemiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: A resident of Berlin, a) who is hospitalized in one of the participating clinics of the Vivantes network, AND b) who is between 18 and 65 years old, AND c) who gave written informed consent to participate in the study, AND d) who is hospitalized due to an acute respiratory illness, defined as presence of the following symptoms in the past 10 days - at least one systemic symptom: fever, or chills, or musclepain, or headache, AND - at least one respiratory symptom: cough or sore throat OR - a suspected diagnosis of influenza, acute bronchitis, or pneumonia assessed by a medical doctor

Exclusion criteria

Exclusion criteria: Patients, a) who can not give written informed consent b) who have insufficient capability to communicate for medical reasons like aphasia or unconsciousness c) who live in a nursing home d) who have a history of severe anaphlaxis after vaccination e) who already had 14 days or earlier before hospitalization the diagnosis of 2009 Novel Influenza confirmed by PCR

Design outcomes

Primary

MeasureTime frame
Assessment of the effectiveness of pandemic influenza vaccines to prevent hospitalization due to acute respiratory illness or due to laboratory-confirmed infection with Novel Influenza A (H1N1) among adults between 18-65 years of age

Secondary

MeasureTime frame
Assessment and description of the disease burden of severe acute respiratory illness among adults between 18-65 years in Berlin on a weekly basis during the flu season 2009/10 || Description of clinical manifestations and complications among patients between 18-65 years of age, who are hospitalized due to 2009 Novel Influenza A (H1N1), and the identification of risk factors for severe disease

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026